Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Not authorised
Participants planned
130
Countries
2
Sites
9
Small Cell Lung Cancer (SCLC) patients who need ≥2nd line treatment without or with brain metastasis which is controlled with no active hemorrhage.
To determine the optimal biological dose (OBD) based on efficacy and safety of each dosing group. ORR for all dosing groups and OBD group plus expansion cohort for = or >2nd line treatment of AL8326 for SCLC patients.
Key facts
- Sponsor
- Advenchen Pharmaceuticals LLC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2024-06-21
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Advenchen Pharmaceuticals, LLC
External identifiers
- EU CT number
- 2023-509067-24-00
- ClinicalTrials.gov
- NCT05363280
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Dose response, Pharmacokinetic, Efficacy, Safety
To determine the optimal biological dose (OBD) based on efficacy and safety of each dosing group.
ORR for all dosing groups and OBD group plus expansion cohort for = or >2nd line treatment of AL8326 for SCLC patients.
Secondary objectives 2
- To measure duration of response (DOR) for expansion cohort study. Progression Free Survival (PFS). To characterize PK profile of single dose and multiple doses, and PK/PD/Efficacy/Safety exposure relationship. Biomarker exploratory study.
- To measure duration of response (DOR) for expansion cohort study. Progression Free Survival (PFS). To characterize PK profile of single dose and multiple doses, and PK/PD/Efficacy/Safety exposure relationship. Biomarker exploratory study.
Conditions and MedDRA coding
Small Cell Lung Cancer (SCLC) patients who need ≥2nd line treatment without or with brain metastasis which is controlled with no active hemorrhage.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10041067 | Small cell lung cancer | 100000004864 |
Study design 2 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Phase 2 Optimal Biological Dose (OBD) finding Treatment randomization will occur centrally using an interactive voice response system or integrated web response system (IVRS/IWRS) or embedded in EDC system.
In Phase 2 OBD stage, patients will be randomized to a daily 40 mg, 60 mg, and 80 mg AL8326 in three cohorts in 1:1:1 ratio. To ensure an approximately balance, =2nd or >2ndline treatment (yes vs no) will be considered as a stratification factor.
|
Randomised Controlled | None | AL8326 40 mg: Patient will be randomized to a daily 40 mg. AL8326 60 mg: Patient will be randomized to a daily 60 mg. AL8326 80 mg: Patient will be randomized to a daily 80 mg. |
|
| 2 | Phase 2 expansion cohort A phase 2 expansion cohort will be continued if a positive clinical result would have been observed after OBD determination. In the Phase 2 expansion cohort of the study, the patient will receive AL8326 at a dose decided based on the OBD part of the study.
|
Not Applicable | None | AL8326: Patients will receive AL8326 at a dose decided based on the OBD part of the study. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1. Male or female, 18 years of age or older. 2. ECOG performance status of 0 or 1. 3. Histologically or cytologically confirmed SCLC. 4. Have at least 1 lesion that meets the criteria for being measurable, as defined by RECIST 1.1. 5. Have a life expectancy of at least 3 months.
Exclusion criteria 1
- Serious, non-healing wound, ulcer or bone fracture Major surgical procedure within 28 days or minor surgical procedure performed within 7 days prior to treatment Active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels Clinically significant cardiovascular disease including uncontrolled hypertension; myocardial infarction or unstable angina within 6 months prior to enrollment; New York Heart Association (NYHA) Grade II or greater congestive heart failure serious cardiac arrhythmia requiring medication; and Grade II or greater peripheral vascular disease Hemoptysis within 3 months prior to enrollment Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19 within 14 days prior to enrollment and during the study unless there is an emergent or life-threatening medical condition that required it.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- OBD and ORR for all dosing groups and OBD group plus expansion cohort
Secondary endpoints 1
- DOR for OBD group plus expansion cohort; PFS; Pharmacokinetic endpoints such as Cmax, AUC and other typic PK parameters; and PK/PD/Efficacy/Safety relationship. Possible biomarker identification
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11090415 · Product
- Active substance
- AL8326
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 80 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ADVENCHEN PHARMACEUTICALS LLC
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Advenchen Pharmaceuticals LLC
- Sponsor organisation
- Advenchen Pharmaceuticals LLC
- Address
- 887 Patriot Drive Suite A
- City
- Moorpark
- Postcode
- 93021-3355
- Country
- United States
Scientific contact point
- Organisation
- Advenchen Pharmaceuticals LLC
- Contact name
- Victoria Rico, M.S. Clinical Project Manager
Public contact point
- Organisation
- Advenchen Pharmaceuticals LLC
- Contact name
- Victoria Rico, M.S. Clinical Project Manager
Third parties 3
| Organisation | City, country | Duties |
|---|---|---|
| Tempus Labs Inc. ORG-100044006
|
Chicago, United States | Laboratory analysis |
| Sofpromed Investigacion Clinica S.L. ORG-100046101
|
Palma, Spain | On site monitoring |
| Bioagilytix Labs LLC ORG-100013030
|
San Diego, United States | Laboratory analysis |
Locations
2 EU/EEA countries · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Not authorised | 15 | 4 |
| Spain | Not authorised | 15 | 5 |
| Rest of world
United States
|
— | 100 | — |
Investigational sites
Istituto Oncologico Veneto
Oncologia Medica 2, Via Gattamelata 64, 35128, Padova
Fondazione IRCCS Istituto Nazionale Dei Tumori
Struttura Complessa di Medicina Oncologica I, Via Giacomo Venezian 1, 20133, Milan
European Institute Of Oncology S.r.l.
Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative, Via Giuseppe Ripamonti 435, 20141, Milan
Fondazione Policlinico Universitario Campus Bio-Medico
Dipartimento di Oncologia Medica, Via Alvaro Del Portillo N 200, 00128, Rome
Vall D'hebron Institut De Recerca
Medical Oncology, Passeig De La Vall D'hebron 119-129, 08035, Barcelona
Hospital Universitario Y Politecnico La Fe
Medical Oncology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Ramon Y Cajal
Medical Oncology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Clinic De Barcelona
Medical Oncology, Calle Villarroel 170, 08036, Barcelona
Complexo Hospitalario Universitario A Coruna
Medical Oncology, Lugar Jubias De Arriba 84, 15006, A Coruna
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-27 | Italy | Not acceptable 2024-06-17
|
2024-06-19 |